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Clinical Trials/NCT04036487
NCT04036487CompletedNot Applicable

Chimay Plastic Surgery Clinic, Taipei

Chih-Cheng Hung1 site in 1 country104 target enrollmentStarted: July 28, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
104
Locations
1
Primary Endpoint
Quality of recovery, postoperative day one

Study Overview

Brief Summary

Among aesthetic or cosmetic surgeries, breast augmentation was the most frequently performed and the endoscopic transaxillary approach has become the preferred incision for Asian women. As breast augmentation must be performed under general anesthesia accompanied by its effects and potential complications, types of general anesthesia may affect the quality of recovery. Currently, the two most common techniques of general anesthesia are inhalation anesthesia (IH) and total intravenous anesthesia (TIVA). The effects of these types of general anesthesia on the quality of recovery have been investigated for numerous surgical procedures. However, no prior studies have analyzed different types of anesthesia used for performing transaxillary endoscopic breast augmentation. This prospective, parallel, randomized controlled study will evaluate the effects of inhalation anesthesia vs. total intravenous anesthesia on the quality of recovery in patients undergoing transaxillary endoscopic breast augmentation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients are appropriate for undergoing transaxillary endoscopic breast augmentation
  • Age between 20-65 years
  • Physical Status I or II as defined by the American Society of Anesthesiologists (ASA) Physical Status Classification System

Exclusion Criteria

  • Having difficulty reading or hearing
  • Diagnosed with addictive disorder
  • Diagnosed with psychiatric disorder
  • Physical Status III-VI as defined by the ASA Physical Status Classification System
  • Presence of acute infection or inflammatory condition (e.g., fever).

Arms & Interventions

IH group

Experimental

Inhalation anesthesia will be given during transaxillary endoscopic breast augmentation.

Intervention: Desflurane (Drug)

TIVA group

Active Comparator

Total intravenous anesthesia will be given during transaxillary endoscopic breast augmentation.

Intervention: Propofol (Drug)

Outcomes

Primary Outcomes

Quality of recovery, postoperative day one

Time Frame: On the 1st postoperative day

Quality of recovery is assessed by the 15-item Quality of Recovery (QoR-15) questionnaire. The total score of the 15-item QoR ranges from 0 to 150, and a higher score indicates a better outcome.

Quality of recovery, postoperative day two

Time Frame: On the 2nd postoperative day

Quality of recovery is assessed by the 15-item Quality of Recovery (QoR-15) questionnaire. The total score of the 15-item QoR ranges from 0 to 150, and a higher score indicates a better outcome.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chih-Cheng Hung
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Chih-Cheng Hung

Superintendent

Chimay Plastic Surgery Clinic

Study Sites (1)

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